Atrial Fibrillation Ablation, Daily Transtelephonic Electrocardiogram, Linear Left Atrial Ablation, Persistent and Long Lasting or Chronic Atrial Fibrillation
Conditions
Brief summary
Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation. Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.
Interventions
OTHERRadiofrequency ablation of heart atrial tissue.
Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration \>1 week) or long-lasting persistent (continuous AF duración \>1 year). * One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient. * Age \>=18 years and written informed consent.
Exclusion criteria
* AF with a reversible cause. * Previous pulmonary veins isolation or left atrial linear ablation. * Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke \<1 month before ablation. * Intracranial haemorrhage \<3 months before ablation. * Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy \<1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter. | through study completion, 1 year follow-up | Atrial fibrillation, atrial tachycardia (atrial flutter). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute intraprocedure efficacy. | during the ablation procedure and up to 2 months blanking perior | Rate of: AF termination to sinus rhythm, organization to atrial tachycardia and non inducibility of AF or atrial tachycardia. |
| Complications. | through study completion, 1year follow-up | Complications associated to the ablation procedure. |
Countries
Spain
Contacts
Primary ContactJosé Luis Merino Llorens, MD, PhD
Outcome results
None listed